MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO AVF NEEDLE TULIP

Model Number FT+152530BC

Device Problem Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/15/2015

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

The incident happened last (b)(6), 2015.The pct was pulling the venous needle while the arterial needle was still completely taped and the venous needle was caught on the arterial tape which made the needle flipped and stuck her left baby (pinky) finger.Went to the hospital for the routine lab for needle stick injury but no further medical intervention was done.

• Brand Name: NIPRO AVF NEEDLE TULIP
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya, ; thailand 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya, ; thailand 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 5067531
• MDR Text Key: 25389451
• Report Number: 8041145-2015-00067
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FT+152530BC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2015
• Distributor Facility Aware Date: 08/17/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/08/2015
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization